Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Trauma; Critical Illness; Oxygen Toxicity

Treatments: Other: Usual Care Oxygenation; Other: Targeted Normoxia (oxygen saturation 90-96%)

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03789396

18-1528

Details and patient eligibility

About

The objective of this study is to conduct an observational pre/post study to evaluate the clinical impact oxygen guideline implementation on oxygen utilization and oxygenation in critically ill trauma patients.

Full description

Supplemental oxygen is fundamental in caring for critically ill trauma. While the avoidance of hypoxia is vital, the current clinical practice of excessive oxygenation settings is common, and unnecessary, and may even be harmful.

An expert panel convened to define optimal oxygenation targets in critically ill trauma patients. The strong consensus was to target normoxia at an oxygen saturation (SpO2) range of 90-96% and arterial oxygen (PaO2) range of 60-100 mmHg. Accordingly, a pilot trial implementation of this consensus will occur for the care of trauma patients.

Specific Aim:

This is an observational pre/post study to evaluate the impact of targeted normoxia implementation in optimizing oxygen delivery and oxygenation in critically ill trauma patients.

Hypotheses:

That the clinical efforts to improve adherence to oxygen guidelines will:

1. improve the proportion of time spent with target normoxia thresholds (oxygen saturation SpO2 90-96%) by
2. reducing utilization of unnecessary supplementation oxygen
3. without a substantive increase in hypoxic episodes or an adverse impact on clinical outcomes.

Enrollment: 572 patients

Sex: All

Ages: 18 to 109 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute Injury/Trauma
• Arrival to Emergency Department

Exclusion criteria

• <18 years of age
• Known prisoners

Trial design

572 participants in 2 patient groups

Pre-implementation

Description:

The control groups will be trauma patients admitted to the ICU 12 months prior to targeted normoxia

Treatment:

Other: Usual Care Oxygenation

Post-implementation

Description:

The intervention group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation.

Treatment:

Other: Targeted Normoxia (oxygen saturation 90-96%)